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SIDNEYNCT04669171

A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorEnterome
Primary completion (estimated)
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Record History

All 10 versions: 8 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Study sites: 12 to 11
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Primary completion date: May 30, 2026 to May 30, 2029v9 Show 6 more changesShow less
    • Primary endpoints: 2 to 3
    • Enrollment target: 60 to 80
    • Study completion date: May 30, 2032 to May 30, 2034
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 5 to 2
    • Site details revised at 2 of 12 sites
  3. Primary completion date: Jun 30, 2025 to May 30, 2026
    • Study sites: 10 to 12
    • Study completion date: Sep 30, 2029 to May 30, 2032
    • Eligibility criteria shortened, about 28 words
    v8
  4. Primary completion date: Sep 30, 2024 to Jun 30, 2025v7
  5. Study sites: 5 to 10v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Apr 15, 2021 to Jul 5, 2021
    v3
  2. Secondary endpoints: 4 to 5v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment |
Timeframe: Up to 24 months
Phase 2: Overall Response Rate
Timeframe: Up to 24 months
Phase 2: Complete Response Rate
Timeframe: Up to 24 months

Secondary (2)

Assessment of the Immunogenicity in Relation to OMP72, OMP64, OMP65, OMP66, and UCP2 that Compose EO2463
Evaluation of Overall Survival

Arms and interventions

Cohort 1Experimental

Safety Lead-In, Dose-Finding, Cohort, with a 3-by-3 design of EO2463 monotherapy for 6 weeks followed by addition of lenalidomide. Then, if applicable rituximab (depending on response with EO2463 + lenalidomide) will be added. Four to 18 previously treated patients with Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) were anticipated to be included based on safety findings.

Cohort 2Experimental

Anticipated approximatively 25 previously untreated patients with FL or MZL with an evaluation of EO2463 monotherapy (at the established dose in Cohort 1).

Cohort 3Experimental

Anticipated approximatively 6 previously untreated patients with FL or MZL with an evaluation of EO2463 (at the established dose in cohort 1) as monotherapy for 6 weeks followed by addition of rituximab if applicable (depending on response with EO2463 monotherapy).

Cohort 4Experimental

Anticipated approximatively 40 patients previously treated patients with FL (or MZL). Evaluation of EO2463 (at the established dose in Cohort 1) in combination with lenalidomide from day 1 and then with addition of rituximab.

Biologicals: EO2463, rituximab

Drugs: lenalidomide

Sites

11 sites in 4 countries

Spain 4, United States 4, Italy 2, France 1